Study On Improving The Quality Standard Of Rhizoma Chuanxiong And Baicalein Capsule Preparation

This paper can be divided into three parts: The first part describes the study on improving the quality standard of Rhizoma Chuanxiong,the second part describes research Baicalein capsule preparation and in vitro dissolution test,the third part is the summarize about progress in the research of Chuanxiong Rhizoma.The first part describes the study on improving the quality standard of Rhizoma Chuanxiong.The HPLC method which using the butylphthalide as substitute references substance,calculated on the relative correction factor of Butylphthalide to ligustilide,and determinated NBP and ligustilide in Rhizoma Chuanxiong.The HPLC method,with methanol-water(52:48)as mobile phase.The column temperature is 35 ℃ and the flow rate is 1.0 m L·min-1.A comparision of the three detection wavelengths indicates that dual-wavelength will be its detection wavelengths.Butylphthalide’s detection wavelength is 230 nm and ligustilide’s Detection wavelength is 330 nm,and make durability investigation for this detection methods of relative correction factor.In order to verified accuracy of substitute method of references substance,external standard method determinated NBP and ligustilide in the 40 kinds of Herbs and decoction pieces of Rhizoma Chuanxiong.The result shows that there is no significant difference between substitute method of references substance and external standard method and the substitute method of references substance was effective and feasible.This research group collected 40 kinds of Herbs and decoction pieces of Rhizoma Chuanxiong and using dual-wavelength and the relative correction factor determinated Butylphthalide and ligustilide in the 40 kinds of Herbs and decoction pieces of Rhizoma Chuanxiong.At the same time,calculated on moisture content in the 40 kinds of Herbs and decoction pieces of Rhizoma Chuanxiong and calculated on Butylphthalide and ligustilide in the dried.Calculated on the dried and Rhizoma Chuanxiong containing butylphthalide shall not be less than 0.030%,ligustilide shall not be less than0.80%;the decoction pieces of Rhizome Chuanxiong containing butylphthalide shall not be less than 0.025%,ligustilide shall not be less than 0.60%.The secend part adopted research Baicalein capsule preparation and in vitro dissolution test,using in-vitro dissolution of Baicalein as review indicators,seleted hydrophilic materials species、disintegrating agent species and the proportion of mian drug and excipients in the single factor experiment;seleted the contents of stuffing bulking agent、the contents of disintegrating agent and the adding method of disintegrating agent in the multifactorial experiment.The prescription was optimized and the prescription was made into Baicalein capsule.The paddle method was used to dissolution test,and calculated the dissolution of Baicalein capsule at various points in time.Then,the dissolution curve in vitro was drawing and the dissolution parameters were obtaining.The best preparation was as follows: Baicalein 10 g,MCC25.4g,CMS-Na(internal added 1.6g),PVP K30 3g;The accumulative dissolution of this drug was up to 87% at 60 min.The prescription can significantly improve the dissolution rate of baicalein,the prescription is reasonable and reliable.To sum up,this paper studies the study on improving the quality standard of Rhizoma Chuanxiong and Baicalein capsule preparation and in vitro dissolution test.The method of determination the content of Butylphthalide and Ligustilide were optimized.According to the determination results of 40 kinds of Herbs and decoction pieces of Rhizoma Chuanxiong,the content limitation of two component were determined.It perfected the quality standard of Herbs and decoction pieces of Rhizoma Chuanxiong.Another part studied out Baicalein capsule preparation and preparation technology.The preparation which made by hydrophilic excipients was economical and practical.Perparation precess was simple,the dissolution of Baicalein capsule was up to 80%.It is suitable to industrial production and provide the beneficial reference for difficult soluble Chinese medicine preparation.